BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN LUMBER CATHETER KIT

    MDR report key: 10275549 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00139
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    February 27, 2020
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K964923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7, H2, H3, H6, H10 UDI -(B)(4). THE CATHETER WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED A LUMBER DRAINAGE CATHETER (ID 821707 - CODMAN LUMBER CATHETER KIT) BECAME DISCONNECTED AFTER THE IMPLANT PROCEDURE, IN THE CRITICAL CARE WARD FOLLOWING TURNING OF THE PATIENT. SOME CSF LOSS, DRAIN WAS REMOVED WITH NO DELAYS OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742405 CODMAN LUMBER CATHETER KIT SHUNT, NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1